Acknowledgements
Special thanks to the medical teams of all the investigational centres and the patients without whom the study could not have been conducted. The sponsor (LFB - Les Ulis, France) supervised all the tasks related to the study: study design and conduct, including the supply of IMPs; the collection, management, analysis, and interpretation of data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Nathalie Dinouel and Eric-Olivier Jaudinot contributed significantly to the study as the sponsor’s project manager and the sponsor’s senior manager, respectively. The contract research organization Euraxi Pharma (Joué-lès-Tours, France) was appointed by the sponsor to coordinate the study. The authors especially thank Virginie Martin (overall project management), Frédérique Léger (data management), Benoit Berge (statistics), Odile Capronnier (medical writing), and the Euraxi’s monitoring team for their contribution to the FIDEL study.